REGULATORY 13/12/13 - O-Opinion on Bismuth citrate

The chemical Bismuth Citrate (CAS 813-93-4) (EC 212-390-1) is a new substance used in hair dye.

First submission was received by the end of January 2009. It includes a complete dossier and the applicant ask for its safety evaluation when used in progressive hair dye formulation at a concentration up to 2.0% in the finished cosmetic product. 

Progressive hair dyes work gradually, with colour build-up over a period of two to three weeks of daily application. With such application, the hair gradually darkens until the required shade is achieved. Thereafter, colour is maintained by up to 3 applications per week. The product is intended for use by middle-aged and older people, principally men.

According to the current US Code of Federal Regulation, bismuth citrate may be safely used in cosmetics intended for colouring hair on the scalp, subject to the following restrictions:- the amount of bismuth citrate in the cosmetic shall not be in excess of 0.5% (w/v); - the cosmetic may not be used for colouring eyelashes, eyebrows or hair on parts of the body other than the scalp. 

SCCS was asked to evaluate if bismuth citrate, used in hair dye at a maximum concentration of 2.0%, could be safe for consumers, but inadequate information has been provided by the applicant, and therefore SCCS concluded that the safety of bismuth citrate cannot be assessed.     

In fact, the quality of the dossier was poor and contains the following major shortcomings:- Although a concentration of 2% of bismuth citrate in cosmetic formulations is applied for, all of the studies submitted for local toxicity testing were performed with a concentration of 0.5%. In addition, supporting data for the concentration claimed was not provided. - Data on identity and/or characterization of bismuth citrate in batches, lots, and formulations was often missing or inadequate. - Data on solubility and/or stability of bismuth citrate in solvents was missing, partly conflicting or inadequate. - The list of references was poorly sorted, titles of the pdf files were partly misleading and several copies were only partly legible. - The only certificate of analysis (CoA) provided was only partly legible.

In order to proceed with the evaluation of the product safety, a complete and adequate physico-chemical characterisation of Bismuth citrate is needed.

Skin and eye irritation studies are required at the concentration of 2% as applied for by the applicant.

The mutagenicity of bismuth citrate can presently not be assessed given the studies provided. A complete set of in vitro studies according to the current Notes of Guidance is required.

REGULATORY 13/12/13 - O-Opinion on Carbon Black (nano-form)

Carbon Black, CI 77266, CAS no. 1333-86-4, EC no. 215-609-9, listed in Annex IV as reference number 126 of the Cosmetic Regulation (EC) No. 1223/2009, is used as colorant in cosmetics, specifically make up products.

Typical use concentrations range from 0.001% to 10% with 0.001% for skin products, 5% for nail enamels and mascaras and up to 10% for other eye decorative products such as eyeliners, eye pencils and eye shadows.

According to the definition established in the Cosmetic Regulation under art. 2. (k), Carbon Black is a nanomaterial.

In fact, the different carbon black materials are characterized by their primary particles size, their aggregation and agglomeration status as well as their impurity profile.

Typically, the average primary particle diameter of commercial carbon black materials range from 10 to 100 nm, while the average aggregate/agglomerate size is in the range 100-800 nm or above. Carbon black is initially formed as roughly spherical primary particles, which, in most cases, rapidly form aggregates.

Accordingly, on the basis of their primary particle size, all Carbon Black/CI 77266 materials are considered as nano-structured materials.

The present dossier evaluates the safety of Carbon Black taking into account most recent recommendations for the safety evaluation of nanomaterials, as the SCCS/1484/12 and ECHA 2012, and it provides an overall safety assessment for this ingredient in nano-form, which takes into account the available information.

On the basis of the available evidence, SCCS has concluded that the use of carbon black in its nano-structured form with a size of 20 nm or larger at a concentration up to 10% as a colorant in cosmetic products, is considered to not pose any risk of adverse effects in humans after application on healthy, intact skin.

Since the skin absorbance studies have only been performed with carbon black nanoparticles  20 nm, additional information will be required on the use of carbon black with particles smaller than 20 nm size intended for use in cosmetic products. 

For what concern mucous membrane irritation studies, an eye irritation potential of carbon black cannot be completely excluded.

Moreover, for cosmetics application, the purity of carbon black nanomaterials should be > 97%, and its impurity profile should comply with FDA specifications with respect to carbon black produced by furnace method.

ASCOPHYSCIENT© y YSALINE© 100

La sociedad francesa Algues et Mer, se ha concentrado desde sus orígenes en dos activos procedentes de algas marinas cultivadas en una zona marítima alrededor de la isla de Ouessant al noroeste de Francia. Se trata de una zona protegida, declarada reserva de la biosfera por la UNESCO.

Ysaline© 100, es un ingrediente activo antimicrobiano obtenido de el alga roja Asparagopsis armata, que sólo Algues & Mer trabaja en todo el mundo. Sus componentes activos son una mezcla de compuestos bromados e iodados.

Su actividad permite reducir el uso de conservantes, además de ser un agente anti-caspa y efectivo en pieles grasas.

Ascophyscient©, es un polivalente activo anti-ageing, que se extra de un alga marrón, Ascophyllum nodosum. 

Su funcionalidad es consecuencia del alto contenido en Fucoidanos, que son poliscáridos sulfatados, con pesos moleculares que van de 100.000 Da a 800.000 Da. Forman un film cutaneo y favorecen la multiplicación del fibroblasto y protegen las fibras de colágeno y elastina.

OLIFEEL® PEARLS

La gama Olifeel ®, de Brasca, comprende una serie de ingredientes obtenidos del aceite de oliva, que permiten formular cosméticos en base a los beneficios de la naturaleza.

Olifeel® Pearls, es un ingrediente de altas prestaciones, que se presenta en forma de pequeñas perlas, que optimizan la seguridad de los trabajadores y el entorno de trabajo, minimizando el riesgo de contaminación. Es rico en triglicéridos vegetales saturados C16-C18 e insaponificables del aceite de oliva, y en su obtención no interviene ningún tratamiento de hidrogenación. Es un versátil y compatible gelificante/modificador de la reología, y es capaz de reemplazar cualquier gelificante sintético o semisintético para fases lipofílicas.

Presenta niveles muy bajos de color y olor, y presenta propiedades antioxidantes y emolientes.

Al ser un producto novedoso se ha requerido un nuevo INCI (Palmitic/Stearic Triglyceride), y se ha presentado la correspondiente patente Italiana.

REGULATORY 10/06/13 - Ot- ISO/DIS 17516

We report that an ISO method was published as  DIS  (Draft International Standard) version.

The objective of this International Standard  (ISO/DIS 17516) is to develop acceptable quantitative and qualitative microbiological limits for cosmetic finished products.

Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Dead line 20/09/2013   

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